olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Product NDC
- 49884-787
- 11-digit product format
- 498840787
- Labeler code
- 49884
- Product ID
- 49884-787_9ce53e8f-235a-4ebc-b1b1-4e764daacab2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA206137
- Marketing category
- ANDA
- Marketing start
- 2016-10-26
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 5; 12.5; 40 mg/1; mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| OLMESARTAN MEDOXOMIL | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M97XTV3HD, 864V2Q084H, 0J48LPH2TH |
| Rxcui | 999967, 999986, 999991, 999996, 1000001 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 49884-787-09 | 2022-09-27 | C162847 | 48780-1 | e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010 |
| 49884-787-11 | 2022-09-27 | C162847 | 48780-1 | e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010 |
| 49884-787-09 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010 |
| 49884-787-11 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-787-09 | olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 23 |
| 49884-787-11 | olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-787 | OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ENDO USA, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20250426_268d12e8-1cfc-4086-b613-8fd94f2d7c4e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-787-09 | 49884078709 | 90 TABLET, FILM COATED in 1 BOTTLE (49884-787-09) | 2016-10-26 | 0000-00-00 | No | No | Current |
| 49884-787-11 | 49884078711 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-787-11) | 2016-10-26 | 0000-00-00 | No | No | Current |